Dietary Intake Modifications to Protect Against Changes in Bone Metabolism (ProK)

National Aeronautics and Space Administration (NASA)

Status: Completed

Conditions: Bone Resorption

Treatments: Other: Preflight; Other: In-flight

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01713634

Pro0225

Details and patient eligibility

About

Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a condition that affects millions of men and women on Earth each year. Many countermeasures to bone loss have been proposed, and many have been evaluated to some degree. To date, those showing potential have focused on either exercise or pharmacological interventions, but none have targeted dietary intake alone as a factor to predict or minimize bone loss during spaceflight. The investigators proposed to document how the ratio of acid precursors to base precursors in the diet is related to directional changes in markers of bone resorption and formation during flight and recovery from flight. There is a high likelihood for success in predicting the extent of bone loss from dietary intake patterns of astronauts during spaceflight, given that this concept is strongly anchored in data obtained from ground-based experiments in our laboratory and others. The notion of manipulating diet to minimize bone loss could also have significant social and economic impacts for NASA and for the general public - especially given the increasing trends for diets that are high in animal protein and low in fruits and vegetables. The results of the proposed experiments will lead to development of a dietary countermeasure for bone loss consisting of a balanced diet with no associated risks for side effects that might be present with pharmaceuticals or supplements, no requirement for payload mass, and no additional crew time necessary during flight.

Enrollment: 17 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Astronauts flying on long-duration (3-6 months) spaceflights

Exclusion criteria

• Non-astronauts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Low Apro/K Diet

Experimental group

Description:

Subjects consume a prescribed diet for 4 days with a low ratio of animal protein to potassium (0.3-0.6 g/mEq).

Treatment:

Other: Preflight

Other: In-flight

High Apro/K Diet

Experimental group

Description:

Subjects consume a prescribed diet that has a high ratio of animal protein to potassium (1.0-1.3 g/mEq) for 4 days.

Treatment:

Other: Preflight

Other: In-flight